Risk-Based Monitoring (RBM)

RBM is an advanced monitoring process that focuses on critical data and processes in a clinical trial. It complements the classic monitoring approach with source data review and centralized monitoring processes. Centralized monitoring is an analysis and evaluation of the collected data and is intended to help identify systemic or site-specific problems, deviations and unreliable data.

Due to its nature, RBM it is less suitable for small studies The exact RBM approach should be described in the monitoring plan.